Drug adverse event reports (FAERS)

Off label use, Swelling, Skin mass

Drugs: STEM CELL, EXOSOME, GROWTH FACTOR OR TISSUE DERIVED UNAPPROVED PRODUCT

SeriousOther seriousReport 26475172
Safetyreportversion
1
Safetyreportid
26475172
Primarysourcecountry
US
Transmissiondateformat
102
Transmissiondate
20260415
Reporttype
1
Serious
1
Seriousnessdeath
2
Seriousnesslifethreatening
2
Seriousnesshospitalization
2
Seriousnessdisabling
2
Seriousnesscongenitalanomali
2
Seriousnessother
1
Receivedateformat
102
Receivedate
20260306
Receiptdateformat
102
Receiptdate
20260306
Fulfillexpeditecriteria
3
Authoritynumb
FDA-CDER-CTU-2026-14330
Primarysource
Reportercountry
US
Qualification
3
Sender
Sendertype
6
Senderorganization
FDA-CTU
Receiver
Receivertype
6
Receiverorganization
FDA
Patient
Patientonsetage
43
Patientonsetageunit
801
Patientweight
51.26
Patientsex
2
Reaction
  1. Reactionmeddraversionpt
    28.1
    Reactionmeddrapt
    Off label use
  2. Reactionmeddraversionpt
    28.1
    Reactionmeddrapt
    Swelling
  3. Reactionmeddraversionpt
    28.1
    Reactionmeddrapt
    Skin mass
Drug
  1. Drugcharacterization
    1
    Medicinalproduct
    STEM CELL, EXOSOME, GROWTH FACTOR OR TISSUE DERIVED UNAPPROVED PRODUCT
    Drugadditional
    4
    Activesubstance
    Activesubstancename
    STEM CELL, EXOSOME, GROWTH FACTOR OR TISSUE DERIVED UNAPPROVED PRODUCTS
Summary
Narrativeincludeclinical
CASE EVENT DATE: 20260306
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How to read this: Each report says someone told FDA an event happened while a product was used. A report does not show the product caused it, and counts rise and fall with how many people report. Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.